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起搏器远程监测对生活质量、功能能力、事件检测及工作量的有效性:PONIENTE试验

Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial.

作者信息

Lopez-Villegas Antonio, Catalan-Matamoros Daniel, Robles-Musso Emilio, Peiro Salvador

机构信息

Division of Medicine, Nordland Hospital, Bodø, Norway.

Institute of Clinical Medicine, Faculty of Health Sciences, University of Tromsø, Tromsø, Norway.

出版信息

Geriatr Gerontol Int. 2016 Nov;16(11):1188-1195. doi: 10.1111/ggi.12612. Epub 2015 Dec 4.

DOI:10.1111/ggi.12612
PMID:26635263
Abstract

AIMS

The purpose of the present study was to assess the effectiveness of the remote monitoring (RM) of older adults with pacemakers on health-related quality of life, functional capacity, feasibility, reliability and safety.

METHODS

The PONIENTE study is a controlled, non-randomized, non-blinded clinical trial, with data collection carried out during the pre-implant stage and after 12 months. Between October of 2012 and November of 2013, 82 patients were assigned to either a remote monitoring group (n = 30) or a conventional hospital monitoring (HM) group (n = 52). The EuroQol-5D (EQ-5D) and the Duke Activity Status Index were used to measure health-related quality of life and functional capacity, respectively. Baseline characteristics and number of hospital visits were also analyzed.

RESULTS

The baseline characteristics of the two study groups were similar for both the EQ-5D (RM 0.74, HM 0.67; P = 0.404) and the Duke Activity Status Index (RM 21.42, HM 19.95; P = 0.272). At the 12-month follow up, the EQ-5D utility score was improved for both groups (RM 0.91, HM 0.81; P = 0.154), unlike the EQ-5D Visual Analog Scale (P = 0.043). The Duke Activity Status Index score was similar to the baseline score. The number of in-hospital visits was 27% lower (3 vs 4; P < 0.001) in the remote group as compared with the hospital group.

CONCLUSIONS

The PONIENTE trial suggests that the remote monitoring of pacemakers in older adults is an equivalent option to hospital monitoring, in terms of health-related quality of life and functional capacity. Furthermore, it allows for the early detection of clinical and pacemaker-related adverse events, and significantly reduces the number of in-hospital visits. Geriatr Gerontol Int 2016; 16: 1188-1195.

摘要

目的

本研究旨在评估对植入起搏器的老年人进行远程监测(RM)在健康相关生活质量、功能能力、可行性、可靠性和安全性方面的有效性。

方法

PONIENTE研究是一项对照、非随机、非盲法的临床试验,在植入前阶段和12个月后进行数据收集。2012年10月至2013年11月期间,82例患者被分为远程监测组(n = 30)或传统医院监测(HM)组(n = 52)。分别使用欧洲五维健康量表(EQ - 5D)和杜克活动状态指数来测量健康相关生活质量和功能能力。还分析了基线特征和住院次数。

结果

对于EQ - 5D(RM组0.74,HM组0.67;P = 0.404)和杜克活动状态指数(RM组21.42,HM组19.95;P = 0.272),两个研究组的基线特征相似。在12个月随访时,两组的EQ - 5D效用评分均有所改善(RM组0.91,HM组0.81;P = 0.154),但EQ - 5D视觉模拟量表评分情况不同(P = 0.043)。杜克活动状态指数评分与基线评分相似。与医院监测组相比,远程监测组的住院次数降低了27%(3次对4次;P < 0.001)。

结论

PONIENTE试验表明,就健康相关生活质量和功能能力而言,对老年人起搏器进行远程监测是与医院监测等效的选择。此外,它有助于早期发现临床及与起搏器相关的不良事件,并显著减少住院次数。《老年医学与老年病学国际杂志》2016年;16:1188 - 1195。

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